UNC Lineberger’s Clinical Immunotherapy Program is conducting chimeric antigen receptor T-cell (CAR-T) clinical trials that are currently open for patient accrual. These experimental treatments involve re-engineering cells from the patient’s immune system to recognize and direct the attack against the patient’s cancer.

Pediatric Trials

Relapsed/Refractory Neuroblastoma

LCCC1743-ATL A Phase I Study of Autologous Activated T-cells expressing a 2nd Generation GD2 Chimeric Antigen Receptor, IL-15, and iCaspase9 Safety Switch Administered To Patients with Relapsed or Refractory Neuroblastoma. This trial combines two different ways of fighting disease: antibodies and T cells. Both antibodies and T cells have been used to treat patients with cancers, and both have shown promise, but neither alone has been sufficient to cure most patients.The primary purpose of this study is to determine whether receiving iC9.GD2.IL-15 T cells is safe and tolerable in patients with relapsed/refractory neuroblastoma. Principal Investigator: George Hucks, MD

CD30+ Lymphoma in patients undergoing autologous stem cell transplant

LCCC1524-ATL Phase I Study of the Administration of T Lymphocytes Expressing the CD30 Chimeric Antigen Receptor (CAR) for Prevention of Relapse of CD30+ Lymphomas after High Dose Therapy and Autologous Stem Transplantation (ATLAS). This study is available to patients with high-risk CD30+ lymphoma who are undergoing an autologous stem cell transplant as therapy. Study participants will receive high-dose chemotherapy and autologous stem cell transplant followed by infusion of autologous CAR T-cells directed against CD30. This study is designed to evaluate the safety of this therapy. Secondary endpoints evaluate the clinical activity of this treatment. Principal Investigator: Thomas C. Shea, MD

Adult Trials

Relapsed/Refractory Multiple Myeloma

LCCC1603-ATL Phase I Study of the Administration of Autologous CAR-T cells Targeting the CD138 Antigen in Patients with Relapsed/Refractory Multiple Myeloma. The primary purpose of this study is to determine whether the administration of CAR T cells targeting CD138 is safe and tolerable and to evaluate an optimal dose of cells to give as treatment. Principal Investigator: Sascha Tuchman, MD

CD30+ Relapsed/Refractory Hodgkin Lymphoma and CD30-expressing T cell lymphoma

LCCC1606-ATL Phase I Study of the Administration of Autologous CAR-T cells Targeting the CD30 Antigen and Expressing CCR4 in Patients with CD30+ Relapsed/Refractory Hodgkin Lymphoma and CD30-expressing T cell lymphoma. The trial evaluates the safety and tolerability of CAR T cells targeting CD30 in patients with CD30-expressing Hodgkin or T cell Lymphoma. The trial also evaluates whether the inclusion of CCR4 into the CAR treatment will enhance the presence of CAR T cells at tumor sites. Principal Investigator: Natalie Grover MD

Relapsed/Refractory Acute Lymphoblastic Leukemia

LCCC1541-ATL Phase I Study of the Administration of Autologous CAR-T Cells Targeting the CD19 Antigen and Containing the Inducible Caspase9 Safety Switch in Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia. The primary purpose of this study is to determine whether receiving iC9-CAR19 cells is safe and tolerable and later to determine an optimal dose of AP1903 to be given to subjects to alleviate severe cytokine release syndrome or neurological complications from CAR T cell therapy. Principal Investigator: Matthew Foster, MD

CD30+ Lymphoma in patients undergoing autologous stem cell transplant

LCCC1524-ATL Phase I Study of the Administration of T Lymphocytes Expressing the CD30 Chimeric Antigen Receptor (CAR) for Prevention of Relapse of CD30+ Lymphomas after High Dose Therapy and Autologous Stem Transplantation (ATLAS). This study is available to patients with high-risk CD30+ lymphoma who are undergoing an autologous stem cell transplant as therapy. Study participants will receive high-dose chemotherapy and autologous stem cell transplant followed by infusion of autologous CAR T-cells directed against CD30. This study is designed to evaluate the safety of this therapy. Secondary endpoints evaluate the clinical activity of this treatment. Principal Investigator: Thomas C. Shea, MD

Relapsed/Refractory CD30+ Hodgkin’s Lymphoma and CD30+ Non-Hodgkin’s Lymphoma

LCCC1532-ATL Phase Ib/II Study of the Administration of T lymphocytes Expressing the CD30 Chimeric Antigen Receptor (CAR) for Relapsed/Refractory CD30+ Hodgkin’s Lymphoma and CD30+ Non-Hodgkin’s Lymphoma. Patients must be 18 years and older. This trial studies the efficacy of CAR T cells targeting CD30 in treating patients with relapsed/refractory CD30+ Hodgkin lymphoma or non-Hodgkin lymphoma that expresses CD30. Patients who have failed treatment with autologous or allogeneic stem cell transplantation are eligible for this therapy. Principal Investigator: Anne Beaven, MD

Relapsed/Refractory B cell Non-Hodgkin Lymphoma

LCCC1813-ATL Administration of Autologous CAR-T Cells Targeting the CD19 Antigen and Containing the Inducible Capsase 9 Safety Switch in Patients with Relapsed/refractory B cell Non-Hodgkin Lymphoma. Principal Investigator: Natalie Grover, MD

Relapsed/Refractory CD30+ Peripheral T Cell Lymphoma

LCCC1904-ATL Phase II Study of the Administration of T Lymphocytes Expressing the CD30 Chimeric Antigen Receptor (CAR) for Relapsed/Refractory CD30+ peripheral T Cell Lymphoma. This is a research study to determine the safety and tolerability of ATLCAR.CD30 for treating relapsed/refractory Peripheral T Cell Lymphoma. To prepare the body for the ATLCAR.CD30 cells, participants will complete lymphodepletion with two chemotherapy agents. Principal Investigator: Anne Beaven, MD

More Information

If you wish to refer a patient or have questions about any of the clinical trials, please contact , 919-445-4208, for more information.